Comparison of Partial Removal and Total Removal of the Corneal Epithelium on Keratoconus

Phase 2

Completed

• Conditions: Keratoconus
• Interventions: Procedure: collagen cross-linking procedure (total removal); Procedure: collagen cross-linking procedure (partial removal)

• Registration Number: NCT01809977
• Lead Sponsor: Isfahan University of Medical Sciences

Brief Summary

The purpose of this study is to determine which surgical method makes less corneal haze

Detailed Description

Keratoconus is an asymmetric, bilateral, progressive non-inflammatory ectasia of the cornea. The investigators evaluate whether partial removal versus total removal of the corneal epithelium can lead to less corneal haze and better visual outcomes.

Study Timeline

• Study Start: 2012-07
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-03
• Study First Submitted: 2013-03-08
• Study First Submitted QC: 2013-03-11
• Last Update Submitted: 2013-03-11
• Study First Posted: 2013-03-13
• Last Update Posted: 2013-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Age between 16-40 years
• axial topography consistent with keratoconus
• minimum corneal thickness more than 400 µm and a progression of keratoconus in past 12 months

Exclusion Criteria

• history of ocular herpes or non-healing corneal ulcers
• subjects with current ocular infection
• severe preoperative corneal haze or scar
• severe ocular surface disease
• autoimmune diseases
• pregnant women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
total removal	collagen cross-linking procedure (total removal)	patients underwent Corneal collagen cross-linking procedure with totally corneal epithelium removing. Total removal was performed by mechanical debridement of the corneal epithelium over the central 9 mm.
partial removal	collagen cross-linking procedure (partial removal)	patients underwent Corneal collagen cross-linking procedure with partially corneal epithelium removing. Partial removal was performed by removing a 3-mm width ring and leaving the central 3 mm of the cornea intact.

Primary Outcome Measures

Name	Time	Method
Best corrected visual acuity	at six months after surgery	determining corrected visual acuity in partial removal versus total removal of the corneal epithelium

Secondary Outcome Measures

Name	Time	Method
Corneal optical density	at six months after surgery	Corneal optical density was assessed by Scheimpflug densitometry

Trial Locations

Locations (1)

Feyz university hospital; 🇮🇷 Isfahan, Iran, Islamic Republic of